MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 S/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 75100856

Device Problems Crack (1135); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that a trial 20 deg 36mm 58-60 g and a trial 20 deg ant+4 36 58-60 g were found broken.A mi z handle acet reamer has a missing spring and a trial femoral head 36 s/+0 is cracked in the peg.It is unknown when this happened or if there was a patient involved.No further information was provided at the time.

Manufacturer Narrative

It was reported that a trial femoral head 36 s/+0 is cracked in the peg.The device, intended for use in treatment, was not returned for investigation.A product evaluation could therefore not be performed.As batch number was not communicated, a review of the production documentation could not be performed either.A complaint history review was performed.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.A relationship between the reported event and the device cannot be confirmed and the root cause of the reported issue remains undetermined.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag", all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Should more information become available, the investigation will be reopened.No further actions are deemed necessary at the time.Smith+nephew will continue to monitor this device for similar issues.

Event Description

It was reported that trial femoral head 36 s/+0 is cracked in the peg.It is unknown when this happened or if there was a patient involved.No further information was provided at the time.

Manufacturer Narrative

G3: report source b5: describe event or problem.E1: name and address.

• Brand Name: TRIAL FEMORAL HEAD 36 S/+0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12712222
• MDR Text Key: 280074212
• Report Number: 9613369-2021-00393
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996121896
• UDI-Public: 07611996121896
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75100856
• Device Catalogue Number: 75100856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 11/15/2021; 01/26/2022
• Supplement Dates FDA Received: 11/16/2021; 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1